Safety Profile of HTX-019 Administered as an Intravenous Push in Cancer Patients: A Retrospective Review.

Abstract

IntroductionHTX-019 [CINVANTI® (aprepitant injectable emulsion)] is a neurokinin 1 receptor antagonist (NK-1 RA) approved as a 30-min infusion for preventing acute and delayed chemotherapy-induced nausea and vomiting. HTX-019 has been generally well tolerated when administered as a 30-min infusion or 2-min injection [intravenous (IV) push] in healthy subjects. This real-world analysis assesses safety of HTX-019 via IV push in patients with cancer and addresses a recent IV bag shortage.MethodsThis retrospective review involved six sites in Alabama, USA. Analyzed patients were 18–94 years old with an Eastern Cooperative Oncology Group performance status ranging from 0 to 4. Seventy-six chemotherapy regimens were utilized (emetogenicity high, n = 35; moderate, n = 35; low, n = 6) and patients received HTX-019 130 mg only or switched from fosaprepitant 150 mg to HTX-019 130 mg within a three-drug antiemetic regimen with a 5-hydroxytryptamine type 3 RA and dexamethasone. HTX-019 was administered via IV push. Electronic medical records of patients receiving HTX-019 were queried for nursing and medical documentation associated with infusion-site adverse events (ISAEs). The detailed notes were also reviewed for any discontinuation of HTX-019 or substitution of HTX-019 with another NK-1 RA.ResultsThe HTX-019 safety profile was analyzed on the basis of 2066 IV push administrations in 591 cancer patients (most common diagnoses: lung, n = 107; breast, n = 100; colon, n = 92). No clinically significant ISAEs or adverse events associated with HTX-019 were reported. Also, no patients discontinued HTX-019 treatment, and none switched from HTX-019 to another NK-1 RA.ConclusionThis is the first study to demonstrate that HTX-019 can be safely administered via IV push in patients with cancer receiving emetogenic chemotherapy while negating the need for fluid bags, which are scarce.FundingHeron Therapeutics, Inc., San Diego, CA, USA.Plain Language SummaryPlain language summary available for this article.